Agencies Issue Rules on Genetic Health Information

Wednesday, October 07, 2009

Three federal agencies – the Department of Labor (DOL), the Department of Health and Human Services (HHS) and the IRS – released in early October two sets of regulations for health plans related to the Genetic Information Nondiscrimination Act of 2008 (GINA).

These regulations were published in the October 7, 2009, edition of the Federal Register. Generally, GINA takes effect for plans years starting on or after May 21, 2009.

The first set of rules is called the “Interim Final Rules Prohibiting Discrimination Based on Genetic Information in Health Insurance Coverage and Group Health Plans.” All three agencies were involved in this rulemaking. These rules take effect for plan years starting 60 days after publication in the Federal Register, on or about December 7, 2009. Genetic information is defined broadly to include not only genetic tests but also family medical history.

For group health plans, GINA prohibits the following forms of genetic discrimination:

• Increasing group premiums based on the results of an individual’s genetic information
• Denying enrollment
• Imposing pre-existing condition exclusions
• Other forms of underwriting based on genetic information

For individual health plans, GINA prohibits carriers from using genetic information to deny coverage, increase premiums or impose pre-existing condition exclusions.

In addition, group health plans and carriers in both the group and individual markets cannot request, require or buy genetic information for underwriting purposes or before and in connection with enrollment. Finally, plans and carriers are generally barred from requesting or requiring individuals to undergo a genetic test.

The second set of rules applies GINA’s requirements to the HIPAA Privacy Rule (45 CFR Parts 160 and 164), making appropriate changes. HHS alone was responsible for this rulemaking. It is a proposed rule that takes effect 180 days after it is finalized. There is a 60-day comment period that starts when the rule is published in the Federal Register.

This rule applies the GINA prohibitions to prohibit health plans from using or disclosing genetic information for underwriting purposes. It clarifies that genetic information – when used by a covered entity – is protected health information (PHI), subject to HIPAA’s use and disclosure rules.